FDA has published a notice in the Federal Register announcing the availability of a final guidance for industry:
This guidance provides information regarding the process by which human generic drug manufacturers and related industry can submit correspondence to FDA requesting information related to generic drug development. This guidance also describes FDA’s process for providing communications related to such correspondence. FDA is issuing this draft guidance as part of the Agency’s implementation of the Generic Drug User Fee Amendments of 2012.
A pre-recorded webinar explaining this final guidance is available here.
On July 9, 2012, the Generic Drug User Fee Amendments of 2012 (GDUFA) was signed into law by the President of the United States of America. GDUFA was designed to speed the delivery of safe, effective, and high-quality generic drugs to the public. This program will bring greater predictability and timeliness to the review of generic drug applications. GDUFA is based on an agreement negotiated by FDA and representatives of the generic drug industry.
If you have any inquiries regarding submitting a controlled correspondence or regarding an assigned controlled correspondence, please direct it to the Control Correspondence Coordinator’s (Saundra Middleton, Marissa McNall and Taylor Burnett) at GenericDrugs@FDA.HHS.GOV. If the inquiry relates to an assigned controlled correspondence include the control number, as well as a copy of the control response.